Method and system for modulating eating behavior by means of neuro-electrical coded signals

ABSTRACT

A method for modulating eating behavior comprising (i) generating at least one confounding neuro-electrical signal that is adapted to modulate the sense of taste in the body, (ii) generating at least one confounding neuro-electrical signal that is adapted to modulate the sense of smell in the body, and (iii) transmitting at least one of the confounding neuro-electrical signals to a subject to modulate the subject&#39;s sense of taste or smell. In a preferred embodiment, both confounding neuro-electrical signals are transmitted to the subject to modulate the subject&#39;s sense of taste and smell.

CROSS-REFERENCE TO PATENT APPLICATIONS

This patent application is a divisional of U.S. patent application Ser.No. 11/430,556 filed on May 8, 2006, entitled “Method and System forModulating Eating Behavior by Means for Neuro-Electrical Coded Signals,”which is hereby incorporated by reference in its entirety. U.S. patentapplication Ser. No. 11/430,556 is a Continuation-in-Part of U.S. patentapplication Ser. No. 10/897,700, which was filed on Jul. 23, 2004 and isalso incorporated herein by reference in its entirety. Thus, the presentapplication traces its priority date to the Jul. 23, 2004 filing date ofU.S. patent application Ser. No. 10/897,700.

TECHNICAL FIELD

Embodiments generally relate to medical methods and systems forcontrolling emotional and instinctual behavior. More particularly, theembodiments relate to modulating eating behavior by means ofneuro-electrical coded signals.

BACKGROUND

As is well known in the art, the emotional and instinctual system of thehuman brain is commonly referred to as the “limbic system”. The limbicsystem provides and controls inborn and acquired behavior. The limbicsystem is also the seat of instincts, emotions, and motivation.

The instinctual and emotional activity (or behavior) of the limbicsystem includes food and water intake, desire, and limits. Thus, theinstinctual and emotional disorders relating thereto, such as compulsiveovereating and other eating disorders, is associated with the limbicsystem.

As is also well known in the art, the brain modulates (or controls)limbic system via electrical signals (Le., action potentials orneuro-electrical signals), which are transmitted through the nervoussystem. The nervous system includes two components: the central nervoussystem, which comprises the brain and the spinal cord, and theperipheral nervous system, which generally comprises groups of nervecells (i.e., neurons) and peripheral nerves that lie outside the brainand spinal cord. The two systems are anatomically separate, butfunctionally interconnected.

As indicated, the peripheral nervous system is constructed of nervecells (or neurons) and glial cells (or glia), which support the neurons.Operative neuron units that carry signals from the brain are referred toas “efferent” nerves. “Afferent” nerves are those that carry sensor orstatus information to the brain.

A typical neuron includes four morphologically defined regions: (i) cellbody, (ii) dendrites, (iii) axon, and (iv) presynaptic terminals. Thecell body (soma) is the metabolic center of the cell. The cell bodycontains the nucleus, which stores the genes of the cell, and the roughand smooth endoplasmic reticulum, which synthesizes the proteins of thecell.

The cell body typically includes two types of outgrowths (or processes):the dendrites and the axon. Most neurons have several dendrites; thesebranch out in tree-like fashion and serve as the main apparatus forreceiving signals from other nerve cells.

The axon is the main conducting unit of the neuron. The axon is capableof conveying electrical signals along distances that range from as shortas 0.1 mm to as long as 2 m. Many axons split into several branches,thereby conveying information to different targets.

Near the end of the axon, the axon is divided into fine branches thatmake contact with other neurons. The point of contact is referred to asa synapse. The cell transmitting a signal is called the presynapticcell, and the cell receiving the signal is referred to as thepostsynaptic cell. Specialized swellings on the axon's branches (i.e.,presynaptic terminals) serve as the transmitting site in the presynapticcell.

Most axons terminate near a postsynaptic neuron's dendrites. However,communication can also occur at the cell body or, less often, at theinitial segment or terminal portion of the axon of the postsynapticcell.

The electrical signals transmitted along the axon interact with thelimbic system, referred to as action potentials, are rapid and transient“all-or-none” nerve impulses. Action potentials typically have anamplitude of approximately 100 millivolts (mV) and a duration ofapproximately 1 msec. Action potentials are conducted along the axon,without failure or distortion, at rates in the range of approximately1-100 meters/sec. The amplitude of the action potential remains constantthroughout the axon, since the impulse is continually regenerated as ittraverses the axon.

A “neurosignal” is a composite signal that includes many actionpotentials. The neurosignal also includes an instruction set for propersystem and organ function. A limbic system neurosignal would thusinclude an instruction set for chewing and swallowing of food, drinkingof water, etc.

Neurosignals or “neuro-electrical coded signals” are thus codes thatcontain complete sets of information for complete system and organfunction. As set forth in Co-Pending application Ser. No. 11/125,480,filed May 9, 2005, once these neurosignals, have been isolated, recordedand standardized, a nerve-specific neuro-electrical signal orinstruction can be generated and transmitted to a subject to control thelimbic system and, hence, treat a multitude of disorders associatedtherewith. The noted disorders include, but are not limited to, variouseating disorders, such as compulsive overeating and obesity, bulimia,and anorexia nervosa.

The increasing prevalence of eating disorders, particularly obesity, inadults (and children) is one of the most serious and widespread healthproblems facing the world community. It is estimated that currently inAmerican 55% of adults are obese and 20% of teenagers are either obeseor significantly overweight. Additionally, 6% of the total population ofthe United States is morbidly obese.

This data is alarming for numerous reasons, not the least of which is itindicates an obesity epidemic. Many health experts believe that obesityis the first or second leading cause of preventable deaths in the UnitedStates, with cigarette smoking either just lagging or leading.

It is the consequences of being overweight that are most alarming.Obesity is asserted to be the cause of approximately eighty percent ofadult onset diabetes in the United States, and of ninety percent ofsleep apnea cases. Obesity is also a substantial risk factor forcoronary artery disease, stroke, chronic venous abnormalities, numerousorthopedic problems, and esophageal reflux disease. More recently,researchers have documented a link between obesity, infertility, andmiscarriages, as well as post menopausal breast cancer.

Despite these statistics, treatment options for obese people arelimited. Classical models combining nutritional counseling with exerciseand education have not led to long term success for very many patients.Use of liquid diets and pharmaceutical agents may result in weight losswhich, however, is only rarely sustained. Surgical procedures that causeeither gastric restriction or malabsorption have been, collectively, themost successful long-term remedy for severe obesity. However, this typeof surgery involves a major operation, can lead to emotional problems,and cannot be modified readily as patient needs demand or change.

Various “electrical stimulation” apparatus, systems, and methods havealso been employed to treat compulsive overeating and obesity.Illustrative are the systems and methods disclosed in U.S. Pat. Nos.5,263,480 and 6,587,719, and U.S. Pat. Application Publications2005/0033376 A1 and 2004/0024428 A1.

The noted “electrical stimulation” systems and methods, as well as mostknown systems, primarily involve the transmission of electrical impulsesto a subject to induce a feeling of nausea and, hence, discourage foodintake by the subject.

It has, however, been recently found that those afflicted with ageosia(i.e, loss of taste) or anosmia (i.e. loss of smell) typically sufferfrom a persistent loss of appetite and/or desire to eat. Modulating (orblocking) the sense of taste and/or the sense of smell in a subject thusprovides an effective means for controlling eating behavior of thesubject and, hence, treating various eating disorders, particularly,compulsive overeating.

It would thus be desirable to provide a method and system for modulatingeating behavior that includes means for generating and transmittingconfounding neuro-electrical signals to a subject that are adapted tomodulate the subject's sense of taste and/or smell, i.e., confound thenaturally generated neuro-electrical signals and thereby restrict thetransfer of information associated with the sense of taste and smell tothe brain. It would also be desirable to provide a method and system formodulating eating behavior that includes means for generating andtransmitting simulated neuro-electrical signals to a subject that areadapted to induce or enhance the subject's sense of taste and/or smell.

It is, therefore, an object of the present invention to provide a methodand system for modulating eating behavior that overcomes the drawbacksassociated with prior art methods and systems for regulating eatingbehaviors.

It is another object of the invention to provide a method and system formodulating eating behavior that includes means for generating at leastone confounding neuro-electrical signal that is adapted to confound atleast one neuro-electrical signal that is generated in the body andassociated with the sense of taste, and thereby restrict the transfer ofinformation associated therewith to the brain when transmitted to thesubject.

It is another object of the invention to provide a method and system formodulating eating behavior that includes means for generating at leastone confounding neuro-electrical signal that is adapted to confound atleast one neuro-electrical signal that is generated in the body andassociated with the sense of smell, and thereby restrict the transfer ofinformation associated therewith to the brain when transmitted to thesubject.

It is another object of the invention to provide a method and system formodulating eating behavior that includes means for generating at leastone simulated neuro-electrical signal that is adapted to induce orenhance the sense of taste when transmitted to a subject.

It is another object of the invention to provide a method and system formodulating eating behavior that includes means for generating at leastone simulated neuro-electrical signal that is adapted to induce orenhance the sense of smell when transmitted to a subject.

It is another object of the invention to provide a method and system formodulating eating behavior that includes means for monitoring foodintake or consumption of a subject.

It is another object of the invention to provide a method and system formodulating eating behavior that includes means for transmittingconfounding or simulated neuro-electrical signals to a subject tomodulate the subject's sense of taste and smell in response to thesubject's food intake exceeding or falling below a predeterminedthreshold level.

It is another object of the invention to provide a method and system formodulating eating behavior that includes means for timed transmission ofconfounding or simulated neuro-electrical signals to a subject, wherebythe subject's sense of taste and/or sense of smell is modulated.

It is another object of the invention to provide a method and system formodulating eating behavior that can be effectively employed to treatvarious eating disorders, including, without limitation, compulsiveeating and obesity, bulimia and anorexia nervosa.

BRIEF SUMMARY

The following summary is provided to facilitate an understanding of someof the innovative features unique to the disclosed embodiments and isnot intended to be a full description. A full appreciation of thevarious aspects of the embodiments disclosed herein can be gained bytaking the entire specification, claims, drawings, and abstract as awhole.

In accordance with the above objects and those that will be mentionedand will become apparent below, in one embodiment of the invention, themethod for modulating eating behavior of a subject includes the steps of(i) generating at least one confounding neuro-electrical signal that isadapted to modulate the sense of taste in the body, and (ii)transmitting the confounding neuro-electrical signal to the subject.

In one embodiment, the modulation comprises restricting the transmissionof afferent information to the brain that is generated in the body andassociated with the sense of taste.

In another embodiment, the modulation comprises substantially abatingthe transmission of afferent information to the brain that is generatedin the body and associated with the sense of taste.

In one embodiment, the confounding neuro-electrical signal istransmitted to the subject at predetermined time intervals.

In one embodiment, the confounding neuro-electrical signal istransmitted to the subject manually.

In another embodiment, the confounding neuro-electrical signal istransmitted to the subject manually and at predetermined time intervals.

In yet another embodiment, a plurality of confounding neuro-electricalsignals is transmitted to the subject.

In accordance with another embodiment of the invention, the method formodulating eating behavior of a subject includes the steps of (i)generating at least one simulated neuro-electrical signal that isadapted to modulate the sense of taste in the body, and (ii)transmitting the simulated neuro-electrical signal to the subject.

Preferably, the simulated neuro-electrical signal substantiallycorresponds to or is representative of a neuro-electrical signal that isgenerated in the body.

In one embodiment, the modulation comprises inducing the sense of tastein the subject's body.

In another embodiment, the modulation comprises enhancing the sense oftaste in the subject's body.

In one embodiment, the simulated neuro-electrical signal is transmittedto the subject at predetermined time intervals.

In one embodiment, the neuro-electrical signal is transmitted manuallyto the subject.

In another embodiment, the simulated neuro-electrical signal istransmitted to the subject manually and at predetermined time intervals.

In yet another embodiment, a plurality of simulated neuro-electricalsignals is transmitted to the subject.

In accordance with another embodiment of the invention, the method formodulating eating behavior of a subject includes the steps of (i)generating at least one confounding neuro-electrical signal that isadapted to modulate the sense of smell in the body, and (ii)transmitting the confounding neuro-electrical signal to the subject.

In one embodiment, the modulation comprises restricting the transmissionof afferent information to the brain that is generated in the body andassociated with the sense of smell.

In another embodiment, the modulation comprises substantially abatingthe transmission of afferent information to the brain that is generatedin the body and associated with the sense of smell.

In one embodiment, the confounding neuro-electrical signal istransmitted to the subject at predetermined time intervals.

In one embodiment, the confounding neuro-electrical signal istransmitted to the subject manually.

In another embodiment, the confounding neuro-electrical signal istransmitted to the subject manually and at predetermined time intervals.

In yet another embodiment, a plurality of confounding neuro-electricalsignals is transmitted to the subject.

In accordance with another embodiment of the invention, the method formodulating eating behavior of a subject includes the steps of (i)generating at least one simulated neuro-electrical signal that isadapted to modulate the sense of smell in the body, and (ii)transmitting the simulated neuro-electrical signal to the subject.

Preferably, the simulated neuro-electrical signal substantiallycorresponds to or is representative of a neuro-electrical signal that isgenerated in the body.

In one embodiment, the modulation comprises inducing the sense of smellin the subject's body.

In another embodiment, the modulation comprises enhancing the sense ofsmell in the subject's body.

In one embodiment, the simulated neuro-electrical signal is transmittedto the subject at predetermined time intervals.

In one embodiment, the neuro-electrical signal is transmitted manuallyto the subject.

In another embodiment, the simulated neuro-electrical signal istransmitted to the subject manually and at predetermined time intervals.

In yet another embodiment, a plurality of simulated neuro-electricalsignals is transmitted to the subject.

In another embodiment of the invention, the method for modulating eatingbehavior of a subject includes the steps of (i) generating at least oneconfounding neuro-electrical signal that is adapted to modulate thesense of taste in the body, (ii) sensing food intake in the subject overat least a first period of time, and (iii) transmitting the confoundingneuro-electrical signal to the subject.

In one embodiment, the modulation comprises restricting the transmissionof afferent information to the brain that is generated in the body andassociated with the sense of smell.

In another embodiment, the modulation comprises substantially abatingthe transmission of afferent information to the brain that is generatedin the body and associated with the sense of smell.

In one embodiment, the confounding neuro-electrical signal istransmitted to the subject if the food intake of the subject exceeds apredetermined threshold level during the first period of time.

In one embodiment, the confounding neuro-electrical signal istransmitted to the subject at predetermined time intervals.

In another embodiment, the confounding neuro-electrical signal istransmitted manually to the subject.

In yet another embodiment, a plurality of confounding neuro-electricalsignals is transmitted to the subject.

In another embodiment of the invention, the method for modulating eatingbehavior of a subject includes the steps of (i) generating at least onesimulated neuro-electrical signal that is adapted to modulate the senseof taste in the body, (ii) sensing food intake in the subject over atleast a first period of time, and (iii) transmitting the simulatedneuro-electrical signal to the subject.

Preferably, the simulated neuro-electrical signal substantiallycorresponds to or is representative of a neuro-electrical signal that isgenerated in the body.

In one embodiment, the modulation comprises inducing the sense of tastein the subject's body.

In another embodiment, the modulation comprises enhancing the sense oftaste in the subject's body.

In one embodiment, the simulated neuro-electrical signal is transmittedto the subject if the food intake of the subject falls below apredetermined threshold level during the first period of time.

In one embodiment, the simulated neuro-electrical signal is transmittedto the subject at predetermined time intervals.

In another embodiment, the simulated neuro-electrical signal istransmitted manually to the subject.

In yet another embodiment, a plurality of simulated neuro-electricalsignals is transmitted to the subject.

In another embodiment of the invention, the method for modulating eatingbehavior of a subject includes the steps of (i) generating at least oneconfounding neuro-electrical signal that is adapted to modulate thesense of smell in the body, (ii) sensing food intake in the subject overat least a first period of time, and (iii) transmitting the confoundingneuro-electrical signal to the subject.

In one embodiment, the modulation comprises restricting the transmissionof afferent information to the brain that is generated in the body andassociated with the sense of smell.

In another embodiment, the modulation comprises substantially abatingthe transmission of afferent information to the brain that is generatedin the body and associated with the sense of smell.

In one embodiment, the confounding neuro-electrical signal istransmitted to the subject if the food intake of the subject exceeds apredetermined threshold level during the first period of time.

In one embodiment, the confounding neuro-electrical signal istransmitted to the subject at predetermined time intervals.

In another embodiment, the confounding neuro-electrical signal istransmitted manually to the subject.

In another embodiment of the invention, the method for modulating eatingbehavior of a subject includes the steps of (i) generating at least onesimulated neuro-electrical signal that is adapted to modulate the senseof smell in the body, (ii) sensing food intake in the subject over atleast a first period of time, and (iii) transmitting the simulatedneuro-electrical signal to the subject.

Preferably, the simulated neuro-electrical signal substantiallycorresponds to or is representative of a neuro-electrical signal that isgenerated in the body.

In one embodiment, the modulation comprises inducing the sense of smellin the subject's body.

In another embodiment, the modulation comprises enhancing the sense ofsmell in the subject's body.

In one embodiment, the simulated neuro-electrical signal is transmittedto the subject if the food intake of the subject falls below apredetermined threshold level during the first period of time,

In one embodiment, the simulated neuro-electrical signal is transmittedto the subject at predetermined time intervals,

In another embodiment, the simulated neuro-electrical signal istransmitted manually to the subject.

In yet another embodiment, a plurality of simulated neuro-electricalsignals is transmitted to the subject.

In each of the noted embodiments, the confounding and simulatedneuro-electrical signals are transmitted to the subject's nervoussystem.

In some embodiments, confounding and simulated neuro-electrical signalsadapted to modulate the sense of taste are transmitted to the subject'sglossopharyngeal nerve (cranial nerve IX).

In sonic embodiments, confounding and simulated neuro-electrical signalsadapted to modulate the sense of smell are transmitted to the subject'sOlfactory nerve complex.

In one embodiment of the invention, the step of transmitting aconfounding or simulated neuro-electrical signal to the subject isaccomplished by direct conduction or transmission through unbroken skinat a zone adapted to communicate with a target nerve, e,g.,glossopharyngeal nerve. Such zone will preferably approximate a positionclose to the nerve or nerve plexus onto which the signal is to beimposed.

In an alternate embodiment of the invention, the step of transmitting aconfounding or simulated neuro-electrical signal to the subject isaccomplished by direct conduction via attachment of an electrode to thereceiving nerve or nerve plexus. This requires a surgical interventionto physically attach the electrode to the selected target nerve.

In yet another embodiment of the invention, the step of transmitting aconfounding or simulated neuro-electrical signal to the subject isaccomplished by transposing the waveform signal into a seismic form in amanner that allows the appropriate “nerve” to receive and obey the codedinstructions of the seismic signal.

According to the invention, a single confounding or simulatedneuro-electrical signal or a plurality of confounding or simulatedneuro-electrical signals can be transmitted to the subject inconjunction with one another.

The system for modulating eating behavior, in accordance with oneembodiment of the invention, generally comprises (i) a processor adaptedto generate at least one confounding or simulated neuro-electricalsignal that is adapted to modulate the sense of taste in the body, and(ii) a signal transmitter adapted to be in communication with asubject's body for transmitting confounding and simulatedneuro-electrical signals to the subject.

In another embodiment of the invention, the system for modulating eatingbehavior comprises (i) a processor adapted to generate at least oneconfounding or simulated neuro-electrical signal that is adapted tomodulate the sense of smell in the body, and (ii) a signal transmitteradapted to be in communication with a subject's body for transmittingconfounding and simulated neuro-electrical signals to the subject.

In another embodiment of the invention, the system for modulating eatingbehavior comprises (i) at least a first food intake sensor adapted tomonitor the food intake of a subject and provide at least a first foodintake signal indicative of the food intake, (ii) a processor incommunication with the food intake sensor adapted to receive the firstfood intake signal, the processor being further adapted to generate atleast one confounding or simulated neuro-electrical signal that isadapted to modulate the sense of taste in the body, and (iii) a signaltransmitter adapted to be in communication with the subject's body fortransmitting confounding and simulated neuro-electrical signals to thesubject.

In another embodiment of the invention, the system for modulating eatingbehavior comprises (i) at least a first food intake sensor adapted tomonitor the food intake of a subject and provide at least a first foodintake signal indicative of the food intake, (ii) a processor incommunication with the food intake sensor adapted to receive the firstfood intake signal, the processor being further adapted to generate atleast one confounding or simulated neuro-electrical signal that isadapted to modulate the sense of smell in the body, and (iii) a signaltransmitter adapted to be in communication with the subject's body fortransmitting confounding and simulated neuro-electrical signals to thesubject.

BRIEF DESCRIPTION OF THE DRAWINGS

The accompanying figures, in which like reference numerals refer toidentical or functionally-similar elements throughout the separate viewsand which are incorporated in and form a part of the specification,further illustrate the present disclosed embodiments and, together withthe detailed description herein, serve to explain the principles of thedisclosed embodiments.

FIG. 1 is a medial view of a brain, showing the pre-frontal limbiccortex and limbic lobe;

FIG. 2 is a further medial view of the brain, showing the deep-lyingstructures of the limbic system;

FIG. 3A is a plan view of a tongue, showing the innervation of theglossopharyngeal and chorda tympani nerves;

FIG. 3B is an illustration of the structures and nerves associated withthe sense of taste, and the communication thereof from the tongue to thebrain;

FIGS. 4A and 4B are illustrations of the nasal structures and nervesassociated with the sense of smell;

FIG. 4C is a schematic illustration of the transfer of olfactoryinformation from the olfactory bulb to the various structures of thebrain;

FIG. 5 is a schematic illustration of one embodiment of a tastemodulation system, according to the invention;

FIG. 6 is a schematic illustration of another embodiment of a tastemodulation system, according to the invention; and

FIG. 7 is a schematic illustration of yet another embodiment of a tastemodulation system, according to the invention.

DETAILED DESCRIPTION

The particular values and configurations discussed in these non-limitingexamples can be varied and are cited merely to illustrate at least oneembodiment and are not intended to limit the scope thereof.

Before describing the present invention in detail, it is to beunderstood that this invention is not limited to particularlyexemplified apparatus, systems, structures or methods as such may, ofcourse, vary. Thus, although a number of apparatus, systems and methodssimilar or equivalent to those described herein can be used in thepractice of the present invention, the preferred materials and methodsare described herein.

It is also to be understood that the terminology used herein is for thepurpose of describing particular embodiments of the invention only andis not intended to be limiting.

Unless defined otherwise, all technical and scientific terms used hereinhave the same meaning as commonly understood by one having ordinaryskill in the art to which the invention pertains.

Further, all publications, patents and patent applications cited herein,whether supra or infra, are hereby incorporated by reference in theirentirety.

Finally, as used in this specification and the appended claims, thesingular forms “a, “an” and “the” include plural referents unless thecontent clearly dictates otherwise. Thus, for example, reference to “awaveform signal” includes two or more such signals; reference to “arespiratory disorder” includes two or more such disorders and the like.

DEFINITIONS

The term “limbic system”, as used herein, means and includes, thegrouping of subcortical structures (i.e., limbic lobe and cortex)disposed proximate the brain stem 10, including, without limitation, theamygdale 12, hippocampus 14, hypothalamus 15, parahippocampal gyrus 16,anterior thalamic nuclei 18, cingulate gyrus 20, olfactory bulb 22,mammillary body 26, medial dorsal nucleus of thalamus 28, cingulum 30,and mammillothalamic tract 32 (see FIGS. 1 and 2).

The term “nervous system”, as used herein, means and includes thecentral nervous system, including the spinal cord, medulla oblongata,pons, cerebellum, midbrain, diencephalon and cerebral hemisphere, andthe peripheral nervous system, including the neurons and glia.

The term “plexus”, as used herein, means and includes a branching ortangle of nerve fibers outside the central nervous system.

The term “ganglion”, as used herein, means and includes a group orgroups of nerve cell bodies located outside the central nervous system.

The term “waveform signal” and “neuro-electrical signal”, as usedherein, mean and include a composite electrical signal that is generatedin the body and carried by neurons in the body, including neurocodes,neurosignals and components and segments thereof, and generatedneuro-electrical signals that substantially correspond thereto.

The term “simulated neuro-electrical signal”, as used herein, means aneuro-electrical signal that produces or enhances the sense of taste orsense of smell in a subject when transmitted thereto.

The term “confounding neuro-electrical signal”, as used herein, meansand includes a neuro-electrical signal that is adapted to confoundneuro-electrical signals that are generated in the body and areassociated with the sense of taste and/or sense of smell, i.e., restrictthe transfer of afferent information to the brain that is associatedwith the sense of taste and/or smell.

The term “eating disorder”, as used herein, means and includes, withoutlimitation, compulsive eating and obesity, bulimia and anorexia nervosa.

The term “eating disorder”, as used herein, means and includescompulsive overeating and obesity, bulimia and anorexia nervosa.

The terms “patient” and “subject”, as used herein, mean and includehumans and animals.

The present invention substantially reduces or eliminates thedisadvantages and drawbacks associated with prior art methods andsystems for modulating or controlling eating behavior. In accordancewith one embodiment of the invention, the method for modulating eatingbehavior of a subject includes the steps of (i) generating at least oneconfounding neuro-electrical signal that is adapted to modulate thesense of taste in the body, and (ii) transmitting the neuro-electricalsignal to the subject.

In one embodiment, the modulation comprises restricting the transmissionof afferent information to the brain that is generated in the body andassociated with the sense of taste. In another embodiment, themodulation comprises substantially abating the transmission of afferentinformation to the brain that is generated in the body and associatedwith the sense of taste.

In accordance with another embodiment of the invention, the method formodulating eating behavior of a subject includes the steps of (i)generating at least one confounding neuro-electrical signal that isadapted to modulate the sense of smell in the body, and (ii)transmitting the confounding neuro-electrical signal to the subject.

In one embodiment, the modulation comprises restricting the transmissionof afferent information to the brain that is generated in the body andassociated with the sense of smell. In another embodiment, themodulation comprises substantially abating the transmission of afferentinformation to the brain that is generated in the body and associatedwith the sense of smell.

In some embodiments, the method for modulating eating behavior of asubject includes the steps of (i) generating at least one confoundingneuro-electrical signal that is adapted to modulate the sense of tastein the body, (ii) generating at least one confounding neuro-electricalsignal that is adapted to modulate the sense of smell in the body, and(ii) transmitting at least one of the confounding neuro-electricalsignals to the subject to modulate the subject's sense of taste orsmell. In a preferred embodiment, both confounding neuro-electricalsignals are transmitted to the subject to modulate the subject's senseof taste and smell.

Referring now to FIGS. 3A and 3B, there is shown the structures andnerves that are associated with the sense of taste. As is well known inthe art, the sense of taste originates in taste cells that are clusteredin taste buds on the tongue 40, palate, pharynx 43, epiglottis, andupper third of the esophagus. On the tongue 40 taste buds are locatedprimarily in the papillae, which are embedded in the epithelium 42.

As illustrated in FIGS. 3A and 3B, taste buds in the anterior two-thirdsof the tongue (designated 44 a) are innervated by sensory neurons of thegeniculate ganglion 46, whose peripheral branches travel in the chordstympani nerve 48; a branch of the facial nerve, i.e., cranial nerve VIIand its associated intermediate nerve. Taste buds in the posterior thirdof the tongue (designated 44 b) are innervated by sensory neurons of thepetrosal ganglion 50, whose peripheral branches travel in the lingualbranch of the glossopharyngeal nerve 51, i.e. cranial nerve IX. Tastebuds on the palate are innervated by the greater superficial petrosalbranch of cranial nerve VII. The taste buds on the pharynx, epiglottisand esophagus are innervated by the superior laryngeal branch of cranialnerve X 58. Some of the noted nerves also carry somatosensory afferentsthat innervate regions of the tongue 40 surrounding taste buds.

The sensory fibers that receive input from the taste buds (and run incranial nerves VII, IX and X) enter the nucleus of the solitary tract 52in the medulla oblongata 34 where they form synapses on a thin column ofcells in the gustatory area 54 of the rostral and lateral part of thenucleus of the solitary tract 52.

As illustrated in FIG. 3B, neurons in the gustatory area 54 (designated55) project to the thalamus 36, where they terminate in the small cell(parvocellular) region of the ventral posterior medial nucleus 38.Neurons in the parvocellulular region of the thalamus that receive tasteinput project to neurons along the border between the anterior insulaand the frontal perculium is the ipsilateral cerebal cortex 39.

Referring now to FIGS. 4A-4C, the structures and nerves associated withthe sense of smell will now be discussed in detail. The initial eventsin olfactory perception occur in olfactory sensory nerves or neurons 62in the nasal cavity 60. These neurons are embedded in the olfactoryepithelium 64, a small patch of specialized epithelium that in humanscovers a region in roof of the nasal cavity 60. The sensory neurons 62project axons 66 to the olfactory bulb 22, which rests on the cribriformplate 68 of the ethmoid bone.

The human olfactory epithelium 64 contains several million olfactorysensory neurons 62 interspersed with glia-like supporting cells, both ofwhich lie above a basal layer of stem cells. Olfactory neurons 62 aredistinctive among neurons in that they are short-lived, with an averagelife span of only approx. 30 days, and are continuously replaced fromthe basal stem cell population.

Referring now to FIG. 4C, the axons and dendrites of the granule mitraland tufted relay neurons (designated 23 a, 23 b, respectively) of theolfactory bulb 22 project through the lateral olfactory tract 25 to theolfactory cortex. The olfactory cortex, defined as that portion of thecortex that receives a direct projection from the olfactory bulb 22, isdivided into five main areas: (i) the anterior olfactory nucleus 70,which connects the two olfactory bulbs 22 through a portion of theanterior commissure; (ii) the piriform cortex 74; (iii) parts of theamygdale 12, (iv) the olfactory tubercle 72; and (v) part of theentorhinal cortex 78. From the latter four areas, information is relayedto the orbitofrontal cortex 80 via the thalamus 36; however, theolfactory cortex also makes direct contacts with the frontal cortex 82.In addition, olfactory information is transmitted from the amygdale 12to the hypothalamus 15 and from the entorhinal area to the hippocampus14.

According to the invention, the confounding neuro-electrical signals ofthe invention can be adapted to restrict or substantially abate thetransmission of afferent information to the brain that is generated inthe body and associated with the sense of taste or smell. Thus, in thecase of a compulsive eating event by a subject, when a confoundingneuro-electrical signal that is adapted to modulate the subject's senseof taste is transmitted to the subject, the confounding satiety signalwould restrict or abate the transmission of afferent informationassociated with the sense of taste to the brain (and limbic system),rendering the subject partially or, more preferably, substantially fullyageusic. When a confounding neuro-electrical signal that is adapted tomodulate the subject's sense of smell is transmitted to the subject, theconfounding neuro-electrical signal would restrict or abate thetransmission of afferent information associated with the sense of smellto the brain, rendering the subject partially or, more preferably,substantially fully anosmic.

As is well known in the art, a subject that is ageusic and/or anosmictypically losses the desire to eat.

According to the invention, the confounding neuro-electrical signals cancomprise various forms and can be adapted to modulate or modifynaturally generated neuro-electrical signals in numerous ways. By way ofexample, in one envisioned embodiment of the invention, at least oneportion of the confounding neuro-electrical signal comprises asubstantially negative mirror image of at least one portion of thenaturally generated neuro-electrical signal, whereby when theconfounding neuro-electrical signal is transmitted to a subject aportion of the naturally generated neuro-electrical signal is modified,e.g., amplitude of the signal and, hence, reduced sense of taste orsmell.

In another envisioned embodiment of the invention, the confoundingneuro-electrical signal is adapted to substantially confound thenaturally generated neuro-electrical signal when transmitted to asubject, i.e., restrict or abate the transmission of afferentinformation embodied in the neuro-electrical signal to the brain.

One suitable confounding neuro-electrical signal is described inCo-Pending U.S. application Ser. No. 11/393,194; which is incorporatedby reference herein.

It will further be appreciated by one having ordinary skill in the artthat the degree or magnitude of the sense of taste and sense of smellcan also be modulated by transmitting confounding (and simulatedneuro-electrical) signals to selective nerves in a subject's body.

In another embodiment of the invention, the method for modulating eatingbehavior of a subject includes the steps of (i) generating at least onesimulated neuro-electrical signal that is adapted to modulate the senseof taste in the body, and (ii) transmitting the simulatedneuro-electrical signal to the subject. In a preferred embodiment, thesimulated neuro-electrical signal substantially corresponds to or isrepresentative of a neuro-electrical signal that is generated in thebody.

In one embodiment, the modulation comprises inducing the sense of tastein the subject's body. In another embodiment, the modulation comprisesenhancing the sense of taste in the subject's body.

In another embodiment of the invention, the method for modulating eatingbehavior of a subject includes the steps of (i) generating at least onesimulated neuro-electrical signal that is adapted to modulate the senseof smell in the body, and (ii) transmitting the simulatedneuro-electrical signal to the subject. In a preferred embodiment, thesimulated neuro-electrical signal similarly substantially corresponds toor is representative of a neuro-electrical signal that is generated inthe body.

In one embodiment, the modulation comprises inducing the sense of smellin the subject's body. In another embodiment, the modulation comprisesenhancing the sense of smell in the subject's body.

As is also well known in the art, inducing or enhancing the sense oftaste and/or smell will enhance a subject's desire to eat.

In some embodiments, the method for modulating eating behavior alsoincludes the step of monitoring the subject's food intake, i.e., thequantity of food consumed. One suitable means for monitoring orascertaining food intake comprises implanting one or more sensingelectrodes in or at the esophagus to detect the passage of food as thesubject swallows. The swallows are then summed over a predetermined timeinterval to estimate the amount of food consumed in that interval.According to the invention, a confounding neuro-electrical signal thatis adapted to modulate the sense of taste or smell or a plurality ofconfounding signals that are adapted to modulate the sense of taste andsmell can then be transmitted to the subject if the estimated foodconsumption exceeds a predetermined threshold level.

Since the caloric intake of similar volumes (or quantities) of twodifferent foods can be significantly different, in one envisionedembodiment of the invention, the method of monitoring (or ascertaining)a subject's food intake includes ascertaining the approximate caloricintake. One suitable means of ascertaining the calories associated witha quantity of selected foods is to include a table of foods andassociated calories or, more preferably, calories per weight or volume,in the control system module or processor (which are described below).

The subject would then input the meal (or desired food) that is about tobe consumed into the system and the system would determine the caloricvalue associated with each inputted food. Based on a preprogrammedcaloric intake, or more preferably, a caloric intake over apredetermined period of time, which is tailored to the subject, thesystem would determine a target, desired range of food intake for theinputted food(s).

Alternatively, the target calories and, hence, volume of food intake canbe determined from various nutritional formulae or a standardizedcaloric table. By way of example, referring to TABLE I (discussedbelow), there is shown a table of estimated amounts of calories neededto maintain energy balance for various gender and age groups at threedifferent levels of physical activity. The noted levels are based onEstimated Energy Requirements (EER) from the Institute of MedicineDietary Reference Intakes macronutrients report, 2002; calculated bygender, age, and activity level for reference-sized individuals.

“Reference size”, as determined by IOM, is based on median height andweight for ages up to age 18 years of age and median height and weightfor that height to give a BMI of 21.5 for adult females and 22.5 foradult males. For more information, please refer to “TABLE I” shown inparagraph [0154] of U.S. Patent Application Publication No.200610206169A1, which published on Sep. 14, 2006, and is based on U.S.patent application Ser. No. 11/430,556, which is incorporated herein byreference in its entirety. Definitions of “sedentary,” “moderatelyactive”, and “active” are also included in U.S. patent application Ser.No. 11/430,556 with respect to TABLE I.

According to the invention, the caloric intake and, hence, quantity offood (i.e., food intake) can be adjusted upward or downward to induceweight loss or weight gain.

Thus, in one embodiment of the invention, the method for modulatingeating behavior of a subject includes the steps of (i) generating atleast one confounding neuro-electrical signal that is adapted tomodulate the sense of taste in the body, (ii) sensing food intake in thesubject over at least a first period of time, and (iii) transmitting theconfounding neuro-electrical signal to the subject.

In one embodiment, the confounding neuro-electrical signal istransmitted to the subject if the food intake of the subject exceeds apredetermined threshold level during the first period of time. Accordingto the invention, when the confounding neuro-electrical signal istransmitted to the subject, the subject loses the sense of taste, i.e.,is rendered ageusic, and loses the desire to eat at a predeterminedlevel of food consumption that is sufficient to maintain physiologicneeds, but supportive of weight reduction.

In another embodiment of the invention, the method for modulating eatingbehavior of a subject includes the steps of (i) generating at least oneconfounding neuro-electrical signal that is adapted to modulate thesense of smell in the body, (ii) sensing food intake in the subject overat least a first period of time, and (iii) transmitting the confoundingneuro-electrical signal to the subject.

In one embodiment, the confounding neuro-electrical signal is similarlytransmitted to the subject if the food intake of the subject exceeds apredetermined threshold level during the first period of time. Accordingto the invention, when the noted confounding neuro-electrical signal istransmitted to the subject, the subject loses the sense of smell, i.e.is rendered anosmic, and similarly loses the desire to eat.

The noted methods of the invention can thus be effectively employed totreat obesity and control excessive overeating. Similar methods can alsobe employed to treat bulimia.

In another embodiment of the invention, the method for modulating eatingbehavior of a subject includes the steps of (i) generating at least onesimulated neuro-electrical signal that is adapted to modulate the senseof taste in the body, (ii) sensing food intake in the subject over atleast a first period of time, and (di) transmitting the simulatedneuro-electrical signal to the subject. According to the invention, themodulation can comprise inducing or enhancing the sense of taste in thesubject's body.

In yet another embodiment of the invention, the method for modulatingeating behavior of a subject includes the steps of (i) generating atleast one simulated neuro-electrical signal that is adapted to modulatethe sense of smell in the body, (ii) sensing food intake in the subjectover at least a first period of time, and (id) transmitting thesimulated neuro-electrical signal to the subject. According to theinvention, the modulation can comprise inducing or enhancing the senseof smell in the subject's body.

According to the invention, when the noted simulated neuro-electricalsignals are transmitted to the subject, the subject experiences a desireto eat.

The noted methods can thus be effectively employed to treat anorexianervosa. The methods can also be employed to modify or control foodconsumption after various surgical procedures.

In alternative embodiments of the invention, the methods include thepre-programmed or timed transmission of either a confounding orsimulated neuro-electrical signal. For example, in the case of an obeseor bulimic subject, a confounding neuro-electrical signal can betransmitted at set intervals at, near and/or between customary mealtimes to render the subject ageusic or anosmic. In the case of ananorexic subject, a simulated neuro-electrical signal can be transmittedat prescribed meal times to enhance to desire to eat.

As discussed in detail herein, alternatively, or in addition withsensing food intake and transmitting a confounding or simulatedneuro-electrical signal in response thereto and/or timed transmission ofa confounding or simulated neuro-electrical signal, the transmission ofthe confounding and simulated neuro-electrical signals can also beaccomplished manually. As will be appreciated by one having skill in theart, manual transmission of a confounding or simulated signal is usefulin situations where the subject has an earnest desire to control his orher eating behavior, but requires supportive measures due toinsufficient will power to refrain from compulsive and/or damagingbehavior.

In some embodiments of the invention, the method for modulating eatingbehavior includes the steps of capturing at least one neuro-electricalsignal from a body that is associated with the sense of taste and/or atleast one neuro-electrical signal from the body that is associated withthe sense of smell.

According to the invention, neuro-electrical signals associated with thesense of taste can be captured or transmitted into cranial nerves V(trigeminal nerve), VII (facial nerve), including the intermediate nerveand chords typani nerve, IX (glossopharyngeal), X (vagus) and XII(hypoglossal). Neuro-electrical signals associated with the sense ofsmell can be captured or transmitted into cranial nerves I (olfactory),IX (glossopharyngeal), including the olfactory tract. The signals canalso be collected directly from nerves associated with the limbicsystem.

Methods and systems for capturing coded signals from the nerve(s), andfor storing, processing and transmitting neuro-electrical signals areset forth in Co-Pending U.S. application Ser. No. 10/000,005, filed Nov.20, 2001, U.S. application Ser. No. 11/125,480, filed May 9, 2005, andU.S. application Ser. No. 11/147,497, filed Jun. 7, 2005; which areincorporated by reference herein in their entirety.

In accordance with one embodiment of the invention, neuro-electricalsignals that are generated in the body and associated with the sense oftaste and/or smell are captured and transmitted to a processor orcontrol module. Preferably, the control module includes storage meansadapted to store the captured signals.

According to the invention, the captured neuro-electrical signals can beprocessed by known means and a simulated neuro-electrical signal that isrepresentative of or substantially similar to at least oneneuro-electrical signal that is generated in the body or a capturedneuro-electrical signal can be generated by the control module. Thenoted neuro-electrical signal is similarly stored in the storage meansof the control module.

Further details of the processor, control module and processing meansare set forth in Co-Pending U.S. application Ser. No. 11/147,497, filedJun. 7, 2005; which is incorporated herein in its entirety.

In response to a pre-programmed event, e.g., food intake exceeding apredetermined threshold level, food intake falling below a predeterminedthreshold level, a pre-programmed period of time or time interval ormanual activation, a generated confounding neuro-electrical signal orsimulated neuro-electrical signal is accessed from the storage means andtransmitted to the subject via a transmitter (or probe).

According to the invention, the applied voltage of confoundingneuro-electrical signals and simulated neuro-electrical signals can beup to 20 volts to allow for voltage loss during the transmission of thesignals. Preferably, current is maintained to less than 2 amp output.

Referring now to FIG. 5, there is shown a schematic illustration of oneembodiment of a taste modulation system 100A of the invention. Accordingto the invention, the smell modulation systems of the invention includethe same components and subsystems as the taste modulation system 100A.The following disclosure relating to various embodiments of the tastemodulation system will thus be equally applicable to the smellmodulation systems of the invention.

As illustrated in FIG. 5, the system 100A includes a control module 102,which is adapted to receive neuro-electrical signals from a signalsensor (shown in phantom and designated 104) that is in communicationwith a subject, and at least one treatment member 106.

The control module 102 is further adapted to generate confoundingneuro-electrical signals and simulated neuro-electrical signals thatsubstantially correspond to or are representative of neuro-electricalsignals that are generated in the body, and transmit the simulatedneuro-electrical signals and confounding neuro-electrical signals to thetreatment member 106 at predetermined periods of time (or timeintervals). The control module 102 is also adapted to transmit thesimulated neuro-electrical signals and confounding neuro-electricalsignals to the treatment member 106 manually, i.e. upon activation of amanual switch (not shown).

The treatment member 106 is adapted to communicate with the body andreceives the confounding neuro-electrical signals and simulatedneuro-electrical signals from the control module 102. According to theinvention, the treatment member 106 can comprise an electrode, antenna,a seismic transducer, or any other suitable form of conductionattachment for transmitting the confounding neuro-electrical signals andsimulated neuro-electrical signals to a subject.

According to the invention, the treatment member 106 can be attached toappropriate nerves via a surgical process. Such surgery can, forexample, be accomplished through a “key-hole” entrance in an endoscopicprocedure. If necessary, a more invasive procedure can be employed formore proper placement of the treatment member 106.

As illustrated in FIG. 5, the control module 102 and treatment member104 can be entirely separate elements, which allow system 100A to beoperated remotely. According to the invention, the control module 102can be unique, i.e., tailored to a specific operation and/or subject, orcan comprise a conventional device.

Referring now to FIG. 6, there is shown a further embodiment of a tastemodulation system 100B of the invention. As illustrated in FIG. 6, thesystem 100B is similar to system 100A shown in FIG. 5. However, in thisembodiment, the control module 102 and treatment member 106 areconnected.

Referring now to FIG. 7, there is shown yet another embodiment of ataste modulation system 100C of the invention. As illustrated in FIG. 7,the control system 100C similarly includes a control module 102 and atreatment member 106,

As illustrated in FIG. 7, the system 100C includes at least one foodintake sensor 110 that is adapted to monitor the food intake orconsumption of a subject and generate at least one signal indicative ofthe food intake, i.e. food intake signal.

As one having ordinary skill in the art will appreciate, various sensingmethods and sensors can be employed within the scope of the invention tomonitor food intake. In one embodiment, the method for monitoring foodintake comprises implanting one or more sensing electrodes in or at theesophagus to detect the passage of food as the subject swallows. Theswallows are then summed over a predetermined time interval to estimatethe amount of food consumed in that interval.

According to the invention, motion and pressure sensors, and otherphysiological devices, such as gastrointestinal bands that are adaptedto sense pressure within a gastrointestinal tract structure or pressurechanges caused by expansion or contraction of a gastrointestinal tractstructure can also be employed.

The system 1000 also includes a processing module (or computer) 103.According to the invention, the processing module 103 can be a separatecomponent or a sub-system of a control module 102, as shown in phantom.The processing module 103 similarly preferably includes storage meansadapted to store the captured neuro-electrical signals, food intakesignals and generated confounding and simulated neuro-electricalsignals.

In a preferred embodiment of the invention, the processor 36 includesstorage means for storing the captured neuro-electrical signals and foodintake signals. The processor 36 is further adapted to extract thecomponents of the neuro-electrical signals and store the signalcomponents in the storage means.

In a preferred embodiment, the control module 103 is programmed to (i)detect when food intake signals reflect that the subject has exceeded apredetermined threshold of food intake in a predetermined period of timeor has not consumed sufficient food over a predetermined period of time,(ii) generate a confounding neuro-electrical signal, and (iii) generatesimulated neuro-electrical signals that modulate the sense of taste andsmell in the body.

The control module 103 is preferably further adapted to transmit theconfounding neuro-electrical signal or simulated neuro-electrical signalto the subject in response to a food intake signal reflecting that thesubject has exceeded a predetermined threshold of food intake in apredetermined period of time, a food intake signal reflecting that thesubject has not consumed a predetermined threshold of food intake in apredetermined period of time, at a predetermined period of time (or timeinterval) and/or manually, i.e., upon activation of a first manualswitch (not shown).

As illustrated in FIG. 7, the confounding neuro-electrical signals andsimulated neuro-electrical signals are routed to a transmitter 106 thatis adapted to be in communication with the subject's body. Thetransmitter 106 is adapted to transmit the confounding and simulatedneuro-electrical signals and confounding satiety signals to the subject(in a similar manner as described above).

According to the invention, each of the systems 100A, 100B and 100Cdescribed above can include at least a second transmitter (shown inphantom and designated 108). By employing multiple transmitters,multiple simulated and/or confounding neuro-electrical signals can betransmitted to two or more different nerves or nerve complexes, wherebythe senses of taste and smell can be substantially simultaneouslymodulated.

In accordance one embodiment of the invention, the method for modulatingeating behavior of a subject thus includes the steps of (i) generatingat least one confounding neuro-electrical signal that is adapted tomodulate the sense of taste in the body, and (ii) transmitting theconfounding neuro-electrical signal to the subject.

In one embodiment, the modulation comprises restricting the transmissionof afferent information to the brain that is generated in the body andassociated with the sense of taste.

In another embodiment, the modulation comprises substantially abatingthe transmission of afferent information to the brain that is generatedin the body and associated with the sense of taste.

In one embodiment, the confounding neuro-electrical signal istransmitted to the subject at predetermined time intervals.

In one embodiment, the confounding neuro-electrical signal istransmitted to the subject manually.

In another embodiment, the confounding neuro-electrical signal istransmitted to the subject manually and at predetermined time intervals.

In yet another embodiment, a plurality of confounding neuro-electricalsignals is transmitted to the subject.

In accordance with another embodiment of the invention, the method formodulating eating behavior of a subject includes the steps of (i)generating at least one simulated neuro-electrical signal that isadapted to modulate the sense of taste in the body, and (ii)transmitting the simulated neuro-electrical signal to the subject.

Preferably, the simulated neuro-electrical signal substantiallycorresponds to or is representative of a neuro-electrical signal that isgenerated in the body.

In one embodiment, the modulation comprises inducing the sense of tastein the subject's body.

In another embodiment, the modulation comprises enhancing the sense oftaste in the subject's body.

In one embodiment, the simulated neuro-electrical signal is transmittedto the subject at predetermined time intervals.

In one embodiment, the neuro-electrical signal is transmitted manuallyto the subject.

In another embodiment, the simulated neuro-electrical signal istransmitted to the subject manually and at predetermined time intervals.

In yet another embodiment, a plurality of simulated neuro-electricalsignals is transmitted to the subject.

In accordance with another embodiment of the invention, the method formodulating eating behavior of a subject includes the steps of (i)generating at least one confounding neuro-electrical signal that isadapted to modulate the sense of smell in the body, and (ii)transmitting the confounding neuro-electrical signal to the subject.

In one embodiment, the modulation comprises restricting the transmissionof afferent information to the brain that is generated in the body andassociated with the sense of smell.

In another embodiment, the modulation comprises substantially abatingthe transmission of afferent information to the brain that is generatedin the body and associated with the sense of smell.

In one embodiment, the confounding neuro-electrical signal istransmitted to the subject at predetermined time intervals.

In one embodiment, the confounding neuro-electrical signal istransmitted to the subject manually.

In another embodiment, the confounding neuro-electrical signal istransmitted to the subject manually and at predetermined time intervals.

In yet another embodiment, a plurality of confounding neuro-electricalsignals is transmitted to the subject.

In accordance with another embodiment of the invention, the method formodulating eating behavior of a subject includes the steps of (i)generating at least one simulated neuro-electrical signal that isadapted to modulate the sense of smell in the body, and (ii)transmitting the simulated neuro-electrical signal to the subject.

Preferably, the simulated neuro-electrical signal substantiallycorresponds to or is representative of a neuro-electrical signal that isgenerated in the body.

In one embodiment, the modulation comprises inducing the sense of smellin the subject's body.

In another embodiment, the modulation comprises enhancing the sense ofsmell in the subject's body.

In one embodiment, the simulated neuro-electrical signal is transmittedto the subject at predetermined time intervals,

In one embodiment, the neuro-electrical signal is transmitted manuallyto the subject.

In another embodiment, the simulated neuro-electrical signal istransmitted to the subject manually and at predetermined time intervals.

In yet another embodiment, a plurality of simulated neuro-electricalsignals is transmitted to the subject.

In another embodiment of the invention, the method for modulating eatingbehavior of a subject includes the steps of (i) generating at least oneconfounding neuro-electrical signal that is adapted to modulate thesense of taste in the body, (ii) sensing food intake in the subject overat least a first period of time, and (iii) transmitting the confoundingneuro-electrical signal to the subject.

In one embodiment, the modulation comprises restricting the transmissionof afferent information to the brain that is generated in the body andassociated with the sense of smell.

In another embodiment, the modulation comprises substantially abatingthe transmission of afferent information to the brain that is generatedin the body and associated with the sense of smell.

In one embodiment, the confounding neuro-electrical signal istransmitted to the subject if the food intake of the subject exceeds apredetermined threshold level during the first period of time.

In one embodiment, the confounding neuro-electrical signal istransmitted to the subject at predetermined time intervals.

In another embodiment, the confounding neuro-electrical signal istransmitted manually to the subject.

In yet another embodiment, a plurality of confounding neuro-electricalsignals is transmitted to the subject.

In another embodiment of the invention, the method for modulating eatingbehavior of a subject includes the steps of (i) generating at least onesimulated neuro-electrical signal that is adapted to modulate the senseof taste in the body, (ii) sensing food intake in the subject over atleast a first period of time, and (iii) transmitting the simulatedneuro-electrical signal to the subject.

Preferably, the simulated neuro-electrical signal substantiallycorresponds to or is representative of a neuro-electrical signal that isgenerated in the body.

In one embodiment, the modulation comprises inducing the sense of tastein the subject's body.

In another embodiment, the modulation comprises enhancing the sense oftaste in the subject's body.

In one embodiment, the simulated neuro-electrical signal is transmittedto the subject if the food intake of the subject falls below apredetermined threshold level during the first period of time.

In one embodiment, the simulated neuro-electrical signal is transmittedto the subject at predetermined time intervals.

In another embodiment, the simulated neuro-electrical signal istransmitted manually to the subject.

In yet another embodiment, a plurality of simulated neuro-electricalsignals is transmitted to the subject.

In another embodiment of the invention, the method for modulating eatingbehavior of a subject includes the steps of (i) generating at least oneconfounding neuro-electrical signal that is adapted to modulate thesense of smell in the body, (ii) sensing food intake in the subject overat least a first period of time, and (iii) transmitting the confoundingneuro-electrical signal to the subject.

In one embodiment, the modulation comprises restricting the transmissionof afferent information to the brain that is generated in the body andassociated with the sense of smell.

In another embodiment, the modulation comprises substantially abatingthe transmission of afferent information to the brain that is generatedin the body and associated with the sense of smell.

In one embodiment, the confounding neuro-electrical signal istransmitted to the subject if the food intake of the subject exceeds apredetermined threshold level during the first period of time.

In one embodiment, the confounding neuro-electrical signal istransmitted to the subject at predetermined time intervals.

In another embodiment, the confounding neuro-electrical signal istransmitted manually to the subject.

In another embodiment of the invention, the method for modulating eatingbehavior of a subject includes the steps of (i) generating at least onesimulated neuro-electrical signal that is adapted to modulate the senseof smell in the body, (ii) sensing food intake in the subject over atleast a first period of time, and (iii) transmitting the simulatedneuro-electrical signal to the subject.

Preferably, the simulated neuro-electrical signal substantiallycorresponds to or is representative of a neuro-electrical signal that isgenerated in the body.

In one embodiment, the modulation comprises inducing the sense of smellin the subject's body.

In another embodiment, the modulation comprises enhancing the sense ofsmell in the subject's body.

In one embodiment, the simulated neuro-electrical signal is transmittedto the subject if the food intake of the subject falls below apredetermined threshold level during the first period of time.

In one embodiment, the simulated neuro-electrical signal is transmittedto the subject at predetermined time intervals.

In another embodiment, the simulated neuro-electrical signal istransmitted manually to the subject.

In yet another embodiment, a plurality of simulated neuro-electricalsignals is transmitted to the subject.

In another embodiment of the invention, the method for modulating eatingbehavior of a subject includes the steps of (i) generating at least afirst confounding neuro-electrical signal that is adapted to modulatethe sense of taste in the body, (ii) generating at least a secondconfounding neuro-electrical signal that is adapted to modulate thesense of smell in the body, (iii) sensing food intake in the subjectover at least a first period of time, and (iv) transmitting the firstand second confounding neuro-electrical signals to the subject when thefood intake of the subject exceeds a predetermined threshold levelduring the first period of time.

In another embodiment of the invention, the method for modulating eatingbehavior of a subject includes the steps of (i) generating at least afirst simulated neuro-electrical signal that is adapted to modulate thesense of taste in the body, (ii) generating at least a second simulatedneuro-electrical signal that is adapted to modulate the sense of smellin the body, (iii) sensing food intake in the subject over at least afirst period of time, and (iv) transmitting the first and secondsimulated neuro-electrical signals to the subject when the food intakeof the subject falls below a predetermined threshold level during thefirst period of time.

In each of the noted embodiments, the confounding and simulatedneuro-electrical signals are transmitted to the subject's nervoussystem.

In some embodiments, confounding and simulated neuro-electrical signalsadapted to modulate the sense of taste are transmitted to the subject'sglossopharyngeal nerve.

In some embodiments, confounding and simulated neuro-electrical signalsadapted to modulate the sense of smell are transmitted to the subject'sOlfactory nerve complex.

In one embodiment of the invention, the step of transmitting aconfounding or simulated neuro-electrical signal to the subject isaccomplished by direct conduction or transmission through unbroken skinat a zone adapted to communicate with a target nerve, e.g.,glossopharyngeal nerve. Such zone will preferably approximate a positionclose to the nerve or nerve plexus onto which the signal is to beimposed.

In an alternate embodiment of the invention, the step of transmitting aconfounding or simulated neuro-electrical signal to the subject isaccomplished by direct conduction via attachment of an electrode to thereceiving nerve or nerve plexus. This requires a surgical interventionto physically attach the electrode to the selected target nerve.

In yet another embodiment of the invention, the step of transmitting aconfounding or simulated neuro-electrical signal to the subject isaccomplished by transposing the waveform signal into a seismic form in amanner that allows the appropriate “nerve” to receive and obey the codedinstructions of the seismic signal.

According to the invention, a single confounding or simulatedneuro-electrical signal or a plurality of confounding or simulatedneuro-electrical signals can be transmitted to the subject inconjunction with one another.

The system for modulating eating behavior, in accordance with oneembodiment of the invention, generally comprises (i) a processor adaptedto generate at least one confounding or simulated neuro-electricalsignal that is adapted to modulate the sense of taste in the body, and(ii) at least one signal transmitter adapted to be in communication witha subject's body for transmitting the confounding and simulatedneuro-electrical signals to the subject.

In another embodiment of the invention, the system for modulating eatingbehavior comprises (i) a processor adapted to generate at least oneconfounding or simulated neuro-electrical signal that is adapted tomodulate the sense of smell in the body, and (ii) a signal transmitteradapted to be in communication with a subject's body for transmittingconfounding and simulated neuro-electrical signals to the subject.

In another embodiment of the invention, the system for modulating eatingbehavior comprises (i) at least a first food intake sensor adapted tomonitor the food intake of a subject and provide at least a first foodintake signal indicative of the food intake, (ii) a processor incommunication with the food intake sensor adapted to receive the firstfood intake signal, the processor being further adapted to generate atleast one confounding or simulated neuro-electrical signal that isadapted to modulate the sense of taste in the body, and (iii) a signaltransmitter adapted to be in communication with the subject's body fortransmitting confounding and simulated neuro-electrical signals to thesubject.

In another embodiment of the invention, the system for modulating eatingbehavior comprises (i) at least a first food intake sensor adapted tomonitor the food intake of a subject and provide at least a first foodintake signal indicative of the food intake, (ii) a processor incommunication with the food intake sensor adapted to receive the firstfood intake signal, the processor being further adapted to generate atleast one confounding or simulated neuro-electrical signal that isadapted to modulate the sense of smell in the body, and (iii) a signaltransmitter adapted to be in communication with the subject's body fortransmitting confounding and simulated neuro-electrical signals to thesubject.

As indicated above, in some embodiments, the system includes two signaltransmitters that are adapted to transmit simulated neuro-electricalsignals and confounding neuro-electrical signals to two different nervesand/or nerve complexes, whereby the senses of taste and smell can besubstantially simultaneously modulated.

EXAMPLES

The following examples are given to enable those skilled in the art tomore clearly understand and practice the present invention. They shouldnot be considered as limiting the scope of the invention, but merely asbeing illustrated as representative thereof.

Example 1

A subject is presented that has an eating disorder. The subject also hasa body mass index greater than forty.

The subject is referred to a nutritionist for nutritional counseling.The subject is also placed on an exercise regime.

The subject is also prescribed taste and smell modulation via a combinedtaste and smell modulation system of the invention.

A first signal transmitter is attached to the subject's glossopharyngealnerve. A second signal transmitter is attached to the subject'sintermediate nerve. A third signal transmitter is attached to thesubject's Olfactory tract.

A first confounding neuro-electrical signal that is adapted to modulatethe subject's sense of taste, i.e., substantially abate the transfer ofafferent information associated with the sense of taste to the subject'sbrain, is generated by the system. A second confounding neuro-electricalsignal that is adapted to modulate the subject's sense of smell, i.e.,substantially abate the transfer of afferent information associated withthe sense of smell to the subject's brain, is generated by the system.

The system is programmed to substantially simultaneously transmit thefirst and second confounding neuro-electrical signals to the subject viathe first and second transmitters every 3 hours and upon manualactivation, whereby the subject is rendered ageusic and anosimic and,hence, temporarily loses the desire to eat.

Example 2

A subject is presented that has an eating disorder, i.e. suffering fromanorexia nervosa.

The subject is prescribed taste and smell modulation via a combinedtaste and smell modulation system of the invention. A first signaltransmitter is attached to the subject's glossopharyngeal nerve. Asecond signal transmitter is attached to the subject's Olfactory tract.

A first simulated neuro-electrical signal that is adapted to modulatethe subject's sense of taste, i.e., enhance the sense of taste, isgenerated by the system. A second simulated neuro-electrical signal thatis adapted to modulate the subject's sense of smell, i.e., sense ofsmell is generated by the system.

The system is programmed to substantially simultaneously transmit thefirst and second simulated neuro-electrical signals to the subject viathe first and second transmitters every 3 hours and upon manualactivation, whereby the subject experiences a desire to eat.

As will be appreciated by one having ordinary skill in the art, thepresent invention has utility in a multitude of medical applications.Among the medical applications are the treatment of the following eatingdisorders:

-   Compulsive overeating-   Obesity-   Bulimia-   Anorexia Nervosa-   Ageusia-   Anosmia

Without departing from the spirit and scope of this invention, one ofordinary skill can make various changes and modifications to theinvention to adapt it to various usages and conditions. As such, thesechanges and modifications are properly, equitably, and intended to be,within the full range of equivalence of the following claims.

1. A method for modulating eating behavior, comprising the steps of:generating at least one confounding neuro-electrical signal that isconfigured to modulate a sense of taste in a body; sensing food intakein a subject over at least a first period of time by implanting one ormore sensing electrodes at an esophagus to detect the passage of foodsaid subject swallows; and transmitting said confoundingneuro-electrical signal to said subject.
 2. The method of claim 1,wherein said modulation comprises restricting the transmission ofafferent information to said subject's brain that is generated in saidsubject's body and associated with the sense of smell.
 3. The method ofclaim 1, wherein said modulation comprises substantially abating saidtransmission of afferent information to said subject's brain that isgenerated in said subject's body and associated with the sense of smell.4. The method of claim 1, wherein said confounding neuro-electricalsignal is transmitted to said subject if said food intake of saidsubject exceeds a predetermined threshold level during said first periodof time.
 5. A method for modulating eating behavior, comprising thesteps of: generating at least one simulated neuro-electrical signal thatis configured to modulate a sense of taste in a body; sensing foodintake in a subject over at least a first period of time by implantingone or more sensing electrodes at an esophagus to detect the passage offood said subject swallows; and transmitting said simulatedneuro-electrical signal to said subject.
 6. The method of claim 5,wherein said simulated neuro-electrical signal substantially correspondsto a neuro-electrical signal that is generated in the body.
 7. Themethod of claim 5, wherein said modulation comprises inducing said senseof taste in said subject's body.
 8. The method of claim 5, wherein saidmodulation comprises enhancing said sense of taste in said subject'sbody.
 9. The method of claim 5, wherein said simulated neuro-electricalsignal is transmitted to said subject if said food intake of saidsubject falls below a predetermined threshold level during said firstperiod of time.
 10. A method for modulating eating behavior, comprisingthe steps of: generating at least one confounding neuro-electricalsignal that is configured to modulate a sense of smell in a body:sensing food intake in a subject over at least a first period of time byimplanting one or more sensing electrodes at an esophagus to detect thepassage of food said subject swallows; and transmitting said confoundingneuro-electrical signal to said subject.
 11. The method of claim 10,wherein said modulation comprises restricting the transmission ofafferent information to said subject's brain that is generated in saidsubject's body and associated with the sense of smell.
 12. The method ofclaim 10, wherein said modulation comprises substantially abating saidtransmission of afferent information to said subject's brain that isgenerated in said subject's body and associated with the sense of smell.13. The method of claim 10, wherein said confounding neuro-electricalsignal is transmitted to said subject if said food intake of saidsubject exceeds a predetermined threshold level during said first periodof time.
 14. A method for modulating eating behavior, comprising thesteps of: generating at least one simulated neuro-electrical signal thatis configured to modulate a sense of smell in a body: sensing foodintake in a subject over at least a first period of time by implantingone or more sensing electrodes at an esophagus to detect the passage offood said subject swallows; and transmitting said simulatedneuro-electrical signal to said subject.
 15. The method of claim 14,wherein said simulated neuro-electrical signal substantially correspondsto a neuro-electrical signal that is generated in the body.
 16. Themethod of claim 14, wherein said modulation comprises inducing saidsense of smell in said subject's body.
 17. The method of claim 14,wherein said modulation comprises enhancing said sense of smell in saidsubject's body.
 18. The method of claim 14, wherein said simulatedneuro-electrical signal is transmitted to said subject if said foodintake of said subject falls below a predetermined threshold levelduring said first period of time.